FDA Adverse Event
Injury
Summary report: N
ACORN 180 RH
MDR report key: 6187380
·
Received December 19, 2016
Report
- Report Number
- 3003124453-2016-00008
- Event Type
- Injury
- Date Received
- December 19, 2016
- Date of Event
- November 5, 2016
- Report Date
- December 9, 2016
- Manufacturer
- ACORN STAIRLIFTS, INC.
- Product Code
- PCD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
CLIENT HAS POLIO AND WEARS A LEG BRACE ON LEFT LEG WHICH WAS BROKEN IN FALL. CAREGIVER REMINDED TO TELL USER TO WEAR SEATBELT AT ALL TIMES WHEN USING LIFT AND TO HAVE ASSISTANCE WITH USE. TECHNICIAN DAMAGED OSG DURING REPAIR, SO NEW OSG FITTED. LIFT REPAIRED AND OPERATING TO SPEC.
Description of Event or Problem · 1
UPON DESCENT, LIFT STOPPED AT LANDING. CLIENT TRIED TO GET OFF LIFT AND FELL DOWN TWO STEPS AND BROKE HER LEFT LEG ON WHICH SHE WEARS A BRACE DUE TO POLIO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837741 | ACORN 180 RH | STAIRWAY CHAIRLIFT, | PCD | ACORN STAIRLIFTS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization | LEG BRACE |